At the request of the U.S. Food and Drug Administration, on Wednesday, U.S. Marshals seized more than $300,000 worth of product, including NC Solution, an antifungal product, and other drugs for human or animal use, dietary supplements, and ingredients to make those products because some lacked FDA approval and all were maintained under grossly unsanitary conditions by General Therapeutics Corp., of St. Louis, Mo.
The FDA considers NC Solution to be a drug because it is intended for the use in the diagnosis, cure, or treatment of disease in people or animals. NC Solution is also a new drug because it is not generally recognized as safe and effective for its intended uses.
Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by the FDA. The company does not have approval for NC Solution.
"The action taken Wednesday is the culmination of the concerted efforts by the FDA to get the firm to follow the law when it comes to manufacturing safe products for consumers," said Margaret O'K. Glavin, FDA Associate Commissioner for Regulatory Affairs.
In August and September, FDA inspectors found that the company was still manufacturing drugs and dietary supplements under unsanitary conditions, including insects and rodent filth on and around manufacturing equipment, despite a warning by FDA of serious violations in 1999. Following the 1999 inspection, a company official told the FDA in January, 2000, it would stop manufacturing drugs.
The FDA recommends that consumers who have any products manufactured by General Therapeutics, including NC Solution, consult their health care provider about discontinuing use and if they have experienced any adverse events that they suspect are related to the product's use.
Catherine L. Hanaway, U.S. Attorney for the Eastern District of Missouri, filed the complaint requesting the seizure, and her office will continue to coordinate with the FDA to ensure proper disposal of the seized items.
The FDA's action against the company is consistent with the agency's initiative on unapproved drugs which pose potentially harmful risks to consumers.
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